study of immune response modifier in the treatment of hematologic malignancies

Conditions: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to evaluate the anti-tumor activity of 852a when used to treat certain hematologic malignancies not responding to standard treatment.

852a will be administered as a subcutaneous injection (sc) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability

Eligibility criteria:
subjects are eligible for the study if they meet all of the following inclusion criteria: * diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia. * acute lymphoblastic leukemia (all) * acute myeloid leukemia (aml) * non-hodgkin's lymphoma (nhl) * hodgkin's lymphoma (hl) * multiple myeloma (mm) * chronic lymphocytic leukemia (cll) * performance status - karnofsky \> 50% for patients \> 10 years of age or lansky \>50% for patients \< 10 year of age * normal organ function within 14 days of study entry * if female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. a female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy exclusion criteria: * had/have the following prior/concurrent therapy: * systemic corticosteroids (oral or injectable) within 7 days of first dose of 852a (topical or inhaled steroids are allowed) * investigational drugs/agents within 14 days of first dose of 852a * immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852a (nitrosoureas within 30 days of first dose) * drugs known to induce qt interval prolongation and/or induce torsades de pointes unless best available drug required to treat life-threatening conditions * radiotherapy within 4 weeks of the first dose of 852a * hematopoietic cell transplantation 4 weeks of first dose of 852a * active infection or fever \> 38.5°c within 3 days of first dose of 852a * cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication * history of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk * uncontrolled intercurrent or chronic illness * active autoimmune disease requiring immunosuppressive therapy within 30 days * active hepatitis b or c with evidence of ongoing viral replication * hyperthyroidism * uncontrolled seizure disorder * active coagulation disorder not controlled with medication * pregnant or lactating * concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated * proven active central nervous system (cns) disease * human immunodeficiency virus (hiv) positive * congenital long qt syndrome or abnormal baseline qtc interval (\> 450 msec in males and \> 470 msec in females) after bazett's correction (qtc msec = qt msec / square root of the rr interval in seconds) on screening electrocardiogram (ecg).

Keywords: leukemia lymphoma myeloma hematology 852a irm oncology